Reduced Oxygen Packaging: Navigating New FDA Guidelines for Food Safety

Packaging Methods

ROP can be achieved through various methods, including:

• Vacuum Packaging: This includes placing food in a vacuum-sealed pouch to preserve freshness. It is used for meats, poultry, seafood, cheeses, and cooked or cured meats.
• Modified Atmosphere Packaging (MAP): This involves replacing the air in the package with a specific gas mixture, usually nitrogen, carbon dioxide, and a bit of oxygen. This atmosphere aims to prolong the shelf life of fresh produce, snacs, baked goods, and ready-to-eat meals.
• Controlled Atmosphere Packaging (CAP): This requires businesses to maintain a specific gas composition in the packaging to preserve freshness longer. It is ideal for storing fresh produce and bulk grains and nuts, slowing down ripening and spoilage.
• Cook-Chill Packaging: This involves cooking food, quickly chilling it to a safe temperature, and vacuum-sealing it in a reduced-oxygen setting. This is best for restaurants, catering, and large-scale food production.
• Sous Vide Packaging: This involves making sure food is vacuum-sealed and cooked slowly in a water bath at low, precise temperatures. Once cooked, it can be quickly chilled and stored in a reduced-oxygen environment until ready for reheating and serving.

Applications of Reduced Oxygen Packaging

ROP is commonly utilized in various industries, including food production, retail, and food service establishments. Here is where you’ll mainly find ROP being used:

Time/Temperature Control for Safety (TCS) Foods 

TCS foods are perishable items that need specific time and temperature controls to stay safe. Extra safety steps, such as creating multiple barriers to stop bacteria growth, strict time and temperature controls, and following a HACCP plan, are necessary. Examples of TCS foods include:

• Poultry, beef, pork
• Fish and shellfish
• Dairy products
• Cut fruits and vegetables

Non-TCS Foods 

Non-TCS foods are more shelf-stable and don’t need strict temperature controls. Using ROP methods on these foods can make them last longer and stay fresher without needing the extra safety measures required for TCS foods. Examples include:

• Breads and baked goods
• Cured meats and cheeses
• Snacks (chips, crackers, etc.)
• Canned goods

Potential Risks

While ROP methods offer significant benefits for extending shelf life and preserving food quality, there are also potential risks to consider, such as:

Anaerobic Bacterial Growth

In ROP, 21% or less oxygen content inside a package can create an ideal environment for the bacteria to grow and produce toxins, which can cause severe foodborne illness. Clostridium Botulinum and Listeria monocytogenes are particularly concerning pathogens that can thrive in reduced-oxygen environments.

Improper Sealing

Another risk is improper sealing, resulting in air entering the package and compromising the reduced-oxygen environment. This happens when packaging equipment is not adequately maintained or package materials are defective.

Undetected Contamination

ROP can also mask the signs of contamination in food, as reduced-oxygen environments slow down or inhibit the growth of bacteria that would typically cause visual changes like discoloration or off-odors.

Undetected Contamination

Even with proper sealing, undetected contamination during packaging is risky. This may occur due to improper food handling or mishandling of equipment. The reduced-oxygen environment can also make detecting contamination through visual changes difficult.

US FDA Guidelines for Reduced Oxygen Packaging

To ensure the safe use of ROP methods, the US Food and Drug Administration (FDA) has established strict guidelines for their use in food packaging. These guidelines include:

Establishing a HACCP Plan

All establishments using ROP methods must have a Hazard Analysis and Critical Control Points (HACCP) plan. This plan outlines the potential hazards of ROP and the critical control points necessary to prevent them. A checklist template is helpful in efficiently developing a HACCP plan.

Allergen Labeling Requirements

Enacted in 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) mandated the labeling major food allergens on FDA-regulated food products. The act specified eight major allergens: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, which account for more than 90% of food allergies in the US.

New US FDA Guidelines

The 2022 version of the US FDA Food Code includes some ROP-related amendments. It revised the definition of ROP for cook-chill methods by removing the requirement to expel air. Other significant changes include:

Time-Temperature Indicators (TTIs)

To enhance the safety of ROP foods, the FDA now requires the use of TTIs on each package if refrigeration below 38°F is the sole method of controlling Clostridium botulinum. TTIs help monitor and ensure that the ROP products remain at the required temperature throughout storage and distribution.

“Use-by date” Labeling

The shelf life of ROP foods depends on storage temperature and factors like low water activity (aw) and preservatives (e.g., salt, nitrites). For cook-chill or sous vide foods without these multiple barriers, storage below 3ºC (38ºF) is required, and the “use-by” date must meet Food Code Section 3-502.12. Here is an example of a use-by-date label for ROP food:

Product Name: Raw Chicken Breasts
Packaged Date: 07/01/2024
Use By Date: 07/15/2024
Keep Refrigerated at 41°F or Below

Variance Requirements

A variance is a special permission that lets a food business follow different rules if they can prove their method is safe. The 2022 FDA Food Code outlines the specific ROP foods that require a variance and guides obtaining one. These include:

1. Unfrozen Processed and Smoked Fish
2. Soft Cheeses
3. Meat or Poultry Products

Cooling Options for Cook-Chill and Sous Vide Foods

The FDA has added four options for cooling cook-chill, and sous vide TCS foods.

Options for food storage:

1. Cool to 1°C (34°F) within 48 hours; keep until used, or discard within 30 days.
2. Keep at 5°C (41°F) for 7 days, then consume or discard.
3. Cool to 1°C (34°F) within 48 hours, then hold at 5°C (41°F) for up to 7 days. Consume or discard within 30 days.
4. Freeze indefinitely until used.

Complying with FDA Guidelines

How can businesses make complying with the new food guidelines more manageable? Implement the following:

Visual Inspection Protocols

Regularly checking for signs of spoilage, contamination, or equipment malfunction can catch issues before they escalate. Establish a routine inspection schedule and train staff to recognize potential hazards. This hands-on approach is essential for identifying issues that automated systems might miss.

Electronic Alarms

Electronic alarm systems can be integrated into refrigeration units, cooking equipment, and storage areas. It provides instant notifications, which help prevent food spoilage and ensure immediate corrective actions are taken.

Continuous Monitoring Solutions

Advancements in technology have introduced continuous monitoring solutions such as telematics and sensors. These devices provide real-time data on various parameters, including temperature, humidity, and equipment performance.

How Sensors Can Help

Sensors are vital to modern continuous monitoring systems, especially for ROP foods. Businesses that utilize sensors can benefit from the following:

Improved Compliance

Sensors help businesses comply strictly with food safety regulations, such as FDA’s. Automated data collection and analysis provide accurate records, simplifying audits and inspections.

Operational Efficiency

Sensors monitor temperature and oxygen level changes, ensuring ROP foods are maintained at safe temperatures. By automating monitoring, businesses can reduce the need for manual checks, freeing up staff to focus on other critical tasks. It further reduces the chances of human error when monitoring temperatures.

Enhanced Food Safety and Quality

Integrating sensors into businesses’ operations can significantly enhance food safety and quality. Continuous monitoring of temperature, humidity, and oxygen levels ensures that ROP foods are stored optimally.